Central Serous Chorioretinopathy risk factors and efficacy of Dorzolamid drop in treatment of patients who attended to ophthalmology clinic of Valiasr hospital of Birjand city in the years 2016_2018
Central Serous Chorioretinopathy risk factors and efficacy of Dorzolamid drop in treatment of patients who attended to ophthalmology clinic of Valiasr hospital of Birjand city from 1/1/2016 to 1/1/2018
Design
A concealed, randomized, blinded, controlled clinical trial.
Settings and conduct
All pateints that comes to ophtalmology clinic of Valiasr hospital that have definite diagnos of Central Serous Retinopathy. They will be divided to two groups that one of them received drop and another just observed, and anyone knows anythings about treatment.
Participants/Inclusion and exclusion criteria
All pateints that come to Valiasr hospital that have definite diagnos of Central Serous Retinopathy
Intervention groups
Pateints divided to two case and control groups for study the efficacy of Dorzolamid drop, that the first group received drop and second group obsereved.
Main outcome variables
Determining the risk factors of central serous retinopathy; efficacy of Dorzolamid drop.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180703040323N1
Registration date:2019-01-12, 1397/10/22
Registration timing:retrospective
Last update:2019-01-12, 1397/10/22
Update count:0
Registration date
2019-01-12, 1397/10/22
Registrant information
Name
Reyhane Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3240 1475
Email address
akhoundi_1358@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Central Serous Chorioretinopathy risk factors and efficacy of Dorzolamid drop in treatment of patients who attended to ophthalmology clinic of Valiasr hospital of Birjand city in the years 2016_2018
Public title
Central Serous Retinopathy risk factors and efficacy of Dorzolamid drop
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients that come to ophtalmology clinic of Valiasr hospital that have definite diagnose of Central Serous Retinopathy with imaging
Exclusion criteria:
Every kind of other Retinopathies
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All volunteers divided to two groups that first group received Dorzolamid drop and second group was observed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2017-09-12, 1396/06/21
Ethics committee reference number
IR.BUMS.REC.1396.142
Health conditions studied
1
Description of health condition studied
Central Serous Retinopathy
ICD-10 code
H35.71
ICD-10 code description
Central serous chorioretinopathy
Primary outcomes
1
Description
Visual Acuity and OCT
Timepoint
Three weeks
Method of measurement
Snellen chart and OCT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dorzolamid drop 2% uses twice a day about 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: follow up for about 3 weeks without anything.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Maryam Yazdani
Street address
Ghaffari Blvd, Valiasr hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3162 2201
Email
akhoundi_1358@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Tooba Kazemi
Street address
Ghaffari Blvd, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reyhane Ebrahimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Ophtalmology
Street address
Ghaffari Blvd, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 8393
Email
akhoundi_1358@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reyhane Ebrahimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Ophtalmology
Street address
Ghaffari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 8393
Email
r_Ebrahimi98@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reyhane Ebrahimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Ophtalmology
Street address
Ghaffari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 8393
Email
r_Ebrahimi98@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of data can be published.
When the data will become available and for how long
start of access is six months after printing conclusions
To whom data/document is available
All people
Under which criteria data/document could be used
No permission
From where data/document is obtainable
r_Ebrahimi98@yahoo.com Reyhane Ebrahimi
What processes are involved for a request to access data/document